Medical vial access device with pressure equalization and closed drug transfer system and method utilizing same

ABSTRACT

A vial access device includes a housing having first and second connectors, with the first connector configured to be secured to a first container and the second connector configured to be secured to a second container. The device also includes a spike member extending from the housing and having a proximal end and a distal end. The spike member defines a vent lumen and a fluid lumen spaced from the vent lumen, with each of the vent lumen and the fluid lumen having a distal opening. The distal openings of the vent lumen and the fluid lumen are each defined by a top edge and a bottom edge spaced axially from the top edge. The bottom edge of the fluid lumen is positioned above the distal opening of the vent lumen in a direction extending along a longitudinal axis of the spike member.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 13/940,809, filed Jul. 12, 2013, which claims the benefit ofU.S. Provisional Application Ser. No. 61/671,567, filed Jul. 13, 2012.The disclosures of each of these applications are hereby incorporated intheir entirety by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a connector device forconnecting a first and a second fluid container. More particularly, thepresent invention relates to a vial connector assembly with an integralpolymeric spike for penetrating a vial stopper and accessing themedicament within a vial.

2. Description of Related. Art

A vial connector assembly is provided to connect a vial to a fluidcontainer to enable the transfer of medicament between the vial andfluid connector.

For instance, a vial connector assembly is typically provided to enablethe transfer of liquid medicament from a vial to a fluid container bymeans of an injector needle, or to enable the transfer of a dissolvingsolvent from a fluid container to a vial storing a dry medicament. Thesame vial connector assembly may also be used to attach a vial to anintravenous fitting to deliver medicament directly from the vial to apatient.

A vial connector assembly typically includes a fluid transfer device,such as a needle or spike that penetrates an elastomeric stopper ormembrane sealing the opening of the vial. The fluid transfer device thusprovides a means for transferring medicament from the vial to a fluidcontainer, a means for introducing solvent into the vial, and a meansfor delivering medicament out of the vial.

Contemporary vial connector assemblies, however, fail to address twoissues related to the transfer of medicament between a vial and a fluidcontainer.

First, there is a potential for hazardous aerosols, particles, andvapors to leak into the environment in contemporary vial assemblies whentransferring liquid medicament from a vial with an injection needle.Consequently, a user may be exposed to hazardous substances consistingof cytotoxic drugs, radio-labeled or allergy-inducing substances thatmay contaminate the user through inhalation or condensation on the skinof a user. Some medicaments are even known to penetrate protectiongloves and thereby contaminate the user. Exposure to contaminations likethis may, on a long term basis, give rise to alarmingly highconcentrations of medicaments in the blood of the user.

Second, there is a potential for coring when the elastomeric stoppers ofvials are pierced by a fluid transfer device, such as a sharp, metalcannulated needle, of contemporary vial connector assemblies. Coringoccurs as an integral vial connector spike or an injection needle isurged through the stopper and the spike or injection needle punches orcuts a small particle of rubber from the stopper. This stopper fragmenteither drops into the vial or becomes lodged in the cannula and ispossibly withdrawn into the syringe. In either case, the sterility ofthe vial contents is compromised and, in the latter case, injection ofparticulate matter into the patient may occur.

Contemporary devices for the aforementioned transfer of medicamentstypically use a hollow pointed spike or needle for piercing anelastomeric vial stopper. Coring results from the vial connector spikeor injection needle cutting a core of stopper material with therelatively sharp edges found at an intersection of an inside diameter ofthe spike or needle and a surface at the end of the spike or needle.These cores represent a potential health hazard if they pass along withthe liquid medication into the patient's body. Also, if the cores arelarge enough or if there are many of them, the stopper may not retainenough material to effectively seal the vial in order to prevent leakageor to protect sterility. In addition, if the device used to puncture thestopper is too large, it may damage the stopper, even in the absence ofany coring, by ripping or tearing the stopper so that it no longereffectively seals the vial.

Additionally, in many applications, the vial contents are repeatedlyaccessed. For instance, many injectable medicaments are packaged inmultidose vials requiring vial access for the withdrawal of each unitdose. Also, many pharmaceuticals are lypholysed in sterile vials forprolonged stability. Such packaging also requires multiple vial entriesto reconstitute the contents and withdrawal of the reconstitutedcontents. The tearing and abrasion caused by multiple vial accesses by asharp injector needle results in pepper-like fragments contaminating thevial contents.

For the reasons stated above, there is a need for a vial connectorassembly that connects a vial to a fluid container while safely enablingthe transfer of medicament between the vial and fluid container whileavoiding leakage or air contamination imparted by the injection needleduring the transfer.

Additionally, there is a need for non-coring spike assembly that allowsthe transfer of medicament to and from a vial with a pierceable stopperwhile incurring minimal stopper damage and requiring minimal penetrationforces.

SUMMARY OF THE INVENTION

In one embodiment, a vial access device includes a housing having firstand second connectors. The first connector is configured to be securedto a first container and the second connector is configured to besecured to a second container. The vial access device further includes aspike member extending from the housing and having a proximal end and adistal end. The spike member defines a vent lumen and a fluid lumenspaced from the vent lumen with each of the vent lumen and the fluidlumen having a distal opening. A shape defined by a circumference of thespike member is only symmetric about one axis at a position between theproximal end of the spike member and the distal opening of the fluidlumen.

The circumference of the spike member may be oval-shaped. Further, thedistal openings of the vent lumen and the fluid lumen may each bedefined by a top edge and a bottom edge spaced axially from the top edgewith outer portions of the top edges of the vent lumen and the fluidlumen being smooth and configured to substantially prevent coring of astopper when penetrating the stopper with the spike member. The topedges of the vent lumen and the fluid lumen may be chamfered. The spikemember may include a ring extending radially outward from the spikemember with the ring being configured to engage a portion of a stopperupon penetrating the stopper with the spike member. Further, acircumference of a portion of the spike member that is positioneddistally of the ring may be larger than a circumference of a portion ofthe spike member that is positioned adjacent to the distal openings ofthe vent and fluid lumens. The distal opening of the vent lumen may beaxially spaced from the distal opening of the fluid lumen and the ventlumen may be positioned closer to the distal end of the spike memberthan the fluid lumen. The distal end of the spike member may be pointedand configured to pierce a stopper. The distal opening of the fluidlumen may extend in a longitudinal direction of the spike member. Thevial access device may include a lubricant coating positioned on thespike member that is positioned adjacent to the distal end of the spikemember.

The vial access device may further include a pressure equalizationchamber in fluid communication with the vent lumen. A pierceablemembrane may be positioned adjacent to the first connector with thepierceable membrane covering a proximal opening of the fluid lumen. Thefirst connector may comprise a neck portion of the housing that definesan opening that is configured to receive a corresponding connector of asyringe adapter. The second connector may comprise a plurality of hookelements configured to engage a medical vial and secure the vial accessdevice to the medical vial.

In a further embodiment, a vial access device includes a housing havingfirst and second connectors with the first connector configured to besecured to a first container and the second connector configured to besecured to a second container. The vial access device further includes aspike member extending from the housing and having a proximal end and adistal end with the spike member defining a vent lumen and a fluid lumenspaced from the vent lumen. Each of the vent lumen and the fluid lumenhave a distal opening with the distal openings of the vent lumen and thefluid lumen each defined by a top edge and a bottom edge spaced axiallyfrom the top edge. An outer portion of the top edges of the vent lumenand the fluid lumen are smooth and configured to substantially preventcoring of a stopper when penetrating the stopper with the spike member.

The top edges of the vent lumen and the fluid lumen may be chamfered.The distal opening of the vent lumen may be axially spaced from thedistal opening of the fluid lumen with the vent lumen positioned closerto the distal end of the spike member than the fluid lumen. The distalend of the spike member may be pointed and configured to pierce astopper, and the distal opening of the fluid lumen may extend in alongitudinal direction of the spike member.

In yet another embodiment, a drug transfer system includes a syringeadapter configured to be secured to a first container and a vial accessdevice. The vial access device has a housing with first and secondconnectors. The first connector is configured to be secured to syringeadapter and the second connector is configured to be secured to a secondcontainer. The vial access device further includes a spike memberextending from the housing and having a proximal end and a distal endwith the spike member defining a vent lumen and a fluid lumen spacedfrom the vent lumen. Each of the vent lumen and the fluid lumen have adistal opening. A shape defined by a circumference of the spike memberis only symmetric about one axis at a position between the proximal endof the spike member and the distal opening of the fluid lumen.

The spike member may include a ring extending radially outward from thespike member with the ring configured to engage a portion of a stopperupon penetrating the stopper with the spike member. A circumference of aportion of the spike member that is positioned distally of the ring maybe larger than a circumference of a portion of the spike member that ispositioned adjacent to the distal openings of the vent and fluid lumens.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages, and novel features of exemplaryembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1 is a bottom left perspective view of one embodiment of a vialaccess device according to one embodiment of the present invention.

FIG. 2 is a bottom right perspective view of the vial access deviceshown in FIG. 1 according to one embodiment of the present invention.

FIG. 3 is a left perspective view of the vial access device shown inFIG. 1 according to one embodiment of the present invention.

FIG. 4 is a right side view of the vial access device shown in FIG. 1according to one embodiment of the present invention.

FIG. 5 is a partial right perspective view of the vial access deviceshown in FIG. 1 according to one embodiment of the present invention.

FIG. 6 is a left side view of the vial access device shown in FIG. 1according to one embodiment of the present invention.

FIG. 7 is a cross-sectional view of the vial access device shown in FIG.1 according to one embodiment of the present invention.

FIG. 8 is a partial cross-sectional view of the vial access device shownin FIG. 1 according to one embodiment of the present invention.

FIG. 9 is a top right perspective view of the vial access device shownin FIG. 1 according to one embodiment of the present invention, showingan expandable bladder in an unexpanded position.

FIG. 10 is a top right perspective view of the vial access device shownin FIG. 1 according to one embodiment of the present invention, showingan expandable bladder in an expanded position.

FIG. 11 is a partial schematic cross-sectional view of the vial accessdevice shown in FIG. 1 according to one embodiment of the presentinvention.

FIG. 12 is a partial front cross-sectional view of the vial accessdevice shown in FIG. 1 according to one embodiment of the presentinvention.

FIG. 13 is a partial bottom cross-sectional view of the vial accessdevice taken along line 15-15, showing a cannula of a syringe adapterreceived within a fluid lumen of the vial access device.

FIG. 14 is a partial bottom cross-sectional view of the vial accessdevice taken along line 14-14 shown in FIG. 12.

FIG. 15 is a partial bottom cross-sectional view of the vial accessdevice taken along line 15-15 shown in FIG. 12.

FIG. 16 is a partial bottom cross-sectional view of the vial accessdevice taken along line 16-16 shown in FIG. 12.

FIG. 17 is a right cross-sectional view of the vial access device shownin FIG. 1 according to one embodiment of the present invention, showingthe vial access device secured to a container.

FIG. 18 is an enlarged right cross-sectional view of the vial accessdevice shown in FIG. 1 according to one embodiment of the presentinvention.

FIG. 19 is a right cross-sectional view of the vial access device shownin FIG. 1 according to one embodiment of the present invention, showingthe vial access device secured to a container.

FIG. 20 is a right cross-sectional view of the vial access device shownin FIG. 1 according to one embodiment of the present invention, showingthe vial access device connected to a syringe adapter and to first andsecond containers.

FIG. 21 is a partial left side view of a vial access device according toa second embodiment of the present invention.

Throughout the drawing figures, like reference numbers will beunderstood to refer to like elements, features, and structures.

DESCRIPTION OF PREFERRED EMBODIMENTS

For purposes of the description hereinafter, spatial orientation terms,if used, shall relate to the referenced embodiment as it is oriented inthe accompanying drawing figures or otherwise described in the followingdetailed description. However, it is to be understood that theembodiments described hereinafter may assume many alternative variationsand embodiments. It is also to be understood that the specific devicesillustrated in the accompanying drawing figures and described herein aresimply exemplary and should not be considered as limiting.

Referring to FIGS. 1-20, one embodiment of a vial access device 10includes a housing 12, a spike member 14, and a pressure equalizationchamber 16. The housing 12 includes a first connector 18 and a secondconnector 20 positioned opposite from the first connector 18. As shownin FIG. 20, the first connector 18 is configured to be secured to afirst container 22, such as a syringe, via a syringe adapter 24. Asshown in FIG. 17, the second connector 20 is configured to be secured toa second container 26, such as a medical vial. The housing 12 may beformed from a polymeric material, such as injection-moldedpolypropylene, although other suitable materials may be utilized. Thefirst connector 18 is formed by a neck portion 28 of the housing 12,which defines first and second guiding grooves 30, 32 that form abayonet-type connection with corresponding structure of the syringeadapter 24. The first and second guiding grooves 30, 32 are configuredto receive and guide the corresponding structure of the syringe adapter24. The first connector 18 is formed integrally with the housing 12,although the first connector 18 may also be formed separately. One typeof connector which can be used for the first connector 18 is disclosedin U.S. Patent Application Publication No. 2011/0125128. The entirecontent of U.S. Patent Application Publication No. 2011/0125128 isincorporated by reference herein.

The second connector 20 includes a plurality of hook elements 34 witheach hook element 34 including a flexible arm 36 having proximal anddistal ends 38, 40. The distal end 40 of each arm 36 has a hookprotrusion 42 configured to engage a corresponding flange 44 of thesecond container 26, which may be a medical vial containing a medicamentas shown in FIG. 17. The flexible arms 36 are configured to moveradially outward upon engaging the second container 26 and subsequentlyreturn to their original position to secure the vial access device 10 tothe second container 26. One type of connector which can be used for thesecond connector 20 is disclosed in U.S. Patent Application PublicationNo. 2010/0147402, which is incorporated by reference herein. As shown inFIG. 7, the second connector 20 may be covered by a protective cap 46prior to use of the vial access device 10. In particular, the protectivecap 46 is snap-fit to the exterior of the hook elements 34 to provideprotection to a user from the spike member 14 and to prevent debris fromentering the spike member 14 prior to use. The cap 46 may be made from apolymeric material, such as polyethylene, although other suitablematerials may be utilized.

Referring still to FIGS. 1-20, the spike member 14 extends from thehousing 12 and includes a proximal end 52 and a distal end 54. The spikemember 12 defines a vent lumen 56 and a fluid lumen 58 spaced from thevent lumen 56. The spike member 14 extends in a direction substantiallyparallel to the plurality of hook elements 34 and includes a pointed tip60 at the distal end 54 of the spike member 14. The spike member 14 isconfigured to pierce the second container 26 during assembly as shown inFIG. 19. The vent lumen 56 and the fluid lumen 58 each include proximal62, 64 and distal openings 66, 68, respectively. As shown in FIG. 20,the fluid lumen 58 is configured to receive a cannula 70 from thesyringe adapter 24, which extends through the housing 12 of the vialaccess device 10 to permit fluid to be transferred through the cannula70 between the first and second containers 22, 26. The fluid lumen 58extends in a longitudinal direction of the spike member 14 between theproximal opening 64 and distal opening 68 of the fluid lumen 58. Thedistal openings 66, 68 of the vent lumen 56 and the fluid lumen 58 areeach defined by a top edge 72, 74 and a bottom edge 76, 78, spacedaxially from the top edge 72, 74, respectively.

A pierceable membrane 80 is positioned adjacent to the first connector18 and covers the proximal opening 64 of the fluid lumen 58. Thepierceable membrane 80 provides a liquid and gas tight seal between thecannula 70 of the syringe adapter 24 and the pierceable membrane 80during fluid transfer to minimize leakage and exposure of hazardousmedicaments to a user. The pierceable membrane 80 may be made from athermoplastic elastomer (TPE), although other suitable materials may beutilized. The vent lumen 56 extends longitudinally from the distal end54 of the spike member 14 to the proximal end 52 of the spike member 14.The vent lumen 56 is aligned substantially parallel with the fluid lumen58. The vent lumen 56 is configured to be in fluid communication withthe pressure equalization chamber 16 as discussed below.

Referring to FIGS. 7 and 8, the spike member 14 also includes a ring 82positioned at the proximal end 52 of the spike member 14. The ring 82extends radially outward from the spike member 14 and is configured toengage a portion of the second container 26 when the spike member 14penetrates a seal 84 of the second container 62, such as a vial stopperof a medical vial. In one embodiment, the ring 82 may rest within theseal 84 of the second container 62 upon insertion of the spike member 14into the second container 62. The ring 82 assists in stabilizing thevial access device 10 when the vial access device 10 is secured to thesecond container 26. In particular, the ring 82 may assist in preventingwobbling or a loose connection between the vial access device 10 and thesecond container 26. The ring 82 extends around the circumference of thespike member 14, although the ring 82 may only extend for a portion ofthe circumference of the spike member 14. Further, the ring 82 may bespaced from the spike member 14 to define an annular space (not shown)between the ring 82 and the spike member 14.

Referring to FIGS. 1-10, the pressure equalization chamber 16 is definedby a hemispherical or parabolic disc 86 having a thin, transparentexpandable bladder 88 made of a flexible, impermeable film such aspolyamide/polypropylene (PA/PP), although other suitable pressureequalization chambers and materials may be utilized. The expandablebladder 88 is movable between an unexpanded state (shown in FIG. 9) andan expanded state (shown in FIG. 10), which acts to maintain apredetermined pressure within the second container 26. The transition ofthe expandable bladder 88 between the unexpanded state and the expandedstate occurs during fluid transfer, which is described in more detailbelow. The pressure equalization chamber 16 is in fluid communicationwith the vent lumen 56 via a pressure chamber channel 90, which extendsabout perpendicular to the vent lumen 56. The pressure chamber channel90 has an opening 92 that is positioned substantially at the center ofthe disc 86. A barrier filter 94 is positioned at the opening 92 of thepressure chamber channel 90 between the pressure equalization chamber 16and the pressure chamber channel 90. In particular, the barrier filter94 covers the opening 92 of the pressure chamber channel 90 and preventsfluid from reaching the expandable bladder 88 and the volume defined bythe disc 86 and the expandable bladder 88. The bather filter 94 ispreferably a hydrophobic filter which permits gas to pass but preventsliquid from passing through. The barrier filter 94 may be made ofpolytetrafluoroethylene (PTFE or Teflon®) with a pore size of between0.1-5 μm and preferably about 3 μm. Upon connecting the vial accessdevice 10 to the second container 26, the pressure equalization chamber16 will be in fluid communication with the second container 26 via thepressure chamber channel 90 and the vent lumen 56.

Referring to FIGS. 17-20, the operation of the vial access device 10,according to one embodiment of the present invention, will be describedin greater detail. The vial access device 10 is assembled via the firstconnector 18 to the syringe adapter 24, which is connected to the firstcontainer 22, such as a syringe. Further, the vial access device 10 issecured to the second container 26 via the second connector 20. Afterassembly, a user is able to introduce fluid into the second container 26and retract fluid from the second container 26. One example of a syringeadapter 24 is disclosed in U.S. Pat. No. 8,075,550. The entire contentof U.S. Pat. No. 8,075,550 is incorporated by reference herein. Duringuse, the vial access device 10 is initially secured to the secondcontainer 26 via the second connector 20 as shown in FIG. 17. The hookelements 34 fixedly connect the vial access device 10 to the secondcontainer 26 as the flexible arms 36 having the hook protrusions 42engage the corresponding flange 44 on the second container 26. As thevial access device 10 is secured to the second container 26, the distalend 54 of the spike member 14, particularly the pointed tip 60, piercesthe stopper or septum 84 that covers and seals the opening of the secondcontainer 26. The syringe adapter 24 and the first container 22 are thensecured to the vial access device 10 via the first connector 18. Asshown in FIG. 20, the corresponding connector of the syringe adapter 24is received by the first connector 18 of the vial access device 10 andreleasably secures the syringe adapter 24 to the vial access device 10.The membrane 80 of the vial access device 10 engages a membrane 96 ofthe syringe adapter 24 when the syringe adapter 24 is secured to thevial access device 10 to form a leak-free connection between the syringeadapter 24 and the vial access device 10.

Referring to FIG. 20, to introduce fluid into the second container 26,the cannula 70 of the syringe adapter 24 pierces the membrane 96 of thesyringe adapter 24 and the membrane 80 of the vial access device 10 andextends through the fluid lumen 58 of the spike member 14. A diluent maybe introduced from the first container 22 through the syringe adapter 24and into the second container 26 via the vial access device 10 toreconstitute a lyophilized medicament contained within the secondcontainer 26. As fluid is introduced through the cannula 70 of thesyringe adapter 24, air within the second container 26 is displacedthrough the vent lumen 56 and the pressure chamber channel 90 and intothe pressure equalization chamber 16, thereby causing the expandablebladder 88 to expand from the unexpanded state shown in FIG. 9 to theexpanded state shown in FIG. 10. The vial access device 10, first andsecond containers 226, 26, and the syringe adapter 24 may then beinverted from the position shown in FIG. 20 to reconstitute themedicament within the second container 26 and subsequently withdraw thereconstituted medicament into the first container 22 using any suitablearrangement, such as through the use of a syringe plunger. Duringtransfer of fluid from the second container 26 to the first container22, the previously displaced air within the pressure equalizationchamber 16 will flow through the pressure chamber channel 90 and thevent lumen 56 into the second container 26, which prevents a vacuum frombeing drawn on the second container 26. At that point, the bladder 88 ofthe pressure equalization chamber 16 will have moved from the expandedstate to the unexpanded state. The cannula 70 of the syringe adapter 24is then withdrawn from the second container 26 and the vial accessdevice 10. The syringe adapter 24 can then be removed from the vialaccess device 10 with the first container 22 having the medicament readyfor transport or delivery to a patient via a suitable arrangement, suchas through an infusion set.

Because the cannula 70 of the syringe adapter 24 extends through thefluid lumen 58 of the spike member 14, the cannula 70 does not have topierce or penetrate the stopper or septum 84 of the second container 26with each access to the second container 26. Accordingly, the tearing,abrasion, and cutting caused by multiple penetrations of the stopper 84by the cannula 70 of the syringe adapter 24 can be eliminated, therebyreducing the possibility of contaminating the contents of the secondcontainer 26 from fragments torn from the stopper 84. The spike member14 of the vial access device 10 allows the contents of the secondcontainer 26 to be emptied with only one penetration of the stopper 84,which reduces the chance of coring of the stopper 84.

The stopper or septum 84 of the second container 26 have various designsbut generally are all press-fitted into the second container 26 to forma radial seal. Certain stopper designs utilize a solid thick body with acoated bottom surface. The rubber material used for the stopper may besubstantially incompressible such that the portion of a device thatpenetrates the stopper needs to displace the same volume of the stopperin the container. In conventional devices, such displacement may lead tocoring of the stopper, which can lead to the removed portion of thestopper blocking the air passage through a vial adapter or falling intothe vial and contaminating its contents.

Referring again to FIGS. 1-20, the spike member 14, according to oneembodiment of the present invention, has a variable cross-section alongits longitudinal length to minimize the volume of the penetrating partof the spike member 14. More specifically, a shape defined by acircumference of the spike member 14 is only symmetric about one axis ata position between the proximal end 52 of the spike member 14 and thedistal opening 68 of the fluid lumen 58. The minimized volume of theoval-shaped spike member 14 serves to minimize the volume of the stopper84 of the second container 26 that needs to be compressed or displaced,thereby reducing coring of the stopper 84.

Referring to FIGS. 12-16, the shape of the circumference andcross-section of the spike member 14 is oval-shaped. The cannula 70 ofthe syringe adapter 24 has an inner diameter D1 and an outer diameterD2. The fluid lumen 58 has an inner diameter of D3, which is preferablyequivalent to D2+(D2−D1). The vent lumen 56 has an inner diameter of D4,which is preferably smaller or equivalent to the inner diameter D1 ofthe cannula 70 of the syringe adapter 24. The flow rate from the cannula70 is maintained due to the smaller or equivalent size of the innerdiameter D1 of the cannula 70 and the diameter D4 of the vent lumen 56.In one embodiment, the width of the oval-shaped spike member 14 alongthe Y-axis is equivalent to D3+3T1+D4 at line 15-15 shown in FIG. 12.The width of the spike member 14 along the X-axis is equivalent toD3+2T1 at line 15-15 shown in FIG. 12. The circumference of the spikemember 14 is continuous without any external splines, ribs, or notches,which seals against the stopper 84 of the second container 26 duringpenetration, thereby preventing leakage that may otherwise occur if theexterior surface was uneven.

In conventional devices, needles with circular-shaped cross-sectionstypically provide adequate leakage protection by sealing against thestopper of a container, such as a medical vial, when accessing the vial.A circular-shaped spike, however, would generate too large of a volumeand lead to coring issues due to the displacement of the stopper of thesecond container by the circular-shaped spike. The oval-shapedcircumference and cross-section of the spike member 14, according to oneembodiment of the present invention, provides leakage protection whileminimizing the volume of the spike member 14.

Referring to FIGS. 14-17, the proximal end 52 of the spike member 14 ismore symmetrical and larger then the distal end 54 of the spike member52. In particular, the shape defined by the circumference of the spikemember 14 adjacent to the distal end 54 of the spike member 14 is onlysymmetrical along one axis as shown in FIG. 15. The proximal end 52 ofthe spike member 14 is more symmetrical and larger in order to seal thespike member 14 against the stopper 84 of the second container 26 toprevent leakage when the vial access device 10 rotates on the secondcontainer 26, which can occur when the syringe adapter 24 is connectedto the vial access device 10 or when the first container 22 is rotated.The distal end 54 of the spike member 14 is smaller compared to proximalportions of the spike member 14 in order to minimize the volume of thespike member 14 and prevent major displacement of the stopper 84 of thesecond container 26 when penetrated by the spike member 14. The spikemember 14 is thinner at the distal end 54, but still has the requiredrigidity to penetrate the stopper 84 of the second container 26. Asshown in FIG. 12, the portion of the spike member 14 positioned distallyfrom the ring 82 tapers in size from the size of the spike member 14shown in FIG. 14 to the size of the spike member 14 shown in FIG. 15. Asdiscussed above, the ring 82 extends radially outward from the spikemember 14 and has a larger circumference than portions of the spikemember 14 positioned distally from the ring 82. Thus, the circumferenceof the portion of the spike member 14 that is positioned distally of thering 82 is larger than a circumference of a portion of the spike member14 that is positioned adjacent to the distal openings 66, 68 of the ventand fluid lumens 56, 58. As shown in FIG. 17, the ring 82 onlypenetrates a portion of the stopper 84 of the second container 26 andacts to stabilize the vial access device 10 when secured to the secondcontainer 26.

Furthermore, in conventional devices, the top edge of the channelopenings of a needle or cannula can cut into the stopper of a fluidcontainer. The spike member 14 according to one embodiment of thepresent invention overcomes this problem by rounding the top edge 72, 74of the distal openings 66, 68 of the vent lumen 56 and the fluid lumen58. The rounding or blunting of the top edge 72, 74 (i.e., the heel) ofthe distal openings 66, 68 of the vent and fluid lumens 56, 58 providesouter portions of the top edges 72, 74 of the vent lumen 56 and thefluid lumen 58 that are smooth to substantially prevent coring of thestopper 84 of the second container 26, such as a medical vial, whenpenetrating the stopper 84 with the spike member 14. The top edge 72, 74of the distal openings 66, 68 of the vent lumen 56 and the fluid lumen58 is chamfered, although other processes may be utilized to providesmooth top edges 72, 74 to prevent coring, such as providing a radius.

Referring to FIG. 18, the distal openings 66, 68 of the vent lumen 56and the fluid lumen 58 are formed by cut-outs C1, C2 and allows for thetop edges 72, 74 of the vent lumen 56 and the fluid lumen 58 to besmooth. The distal openings 66, 68 of the vent lumen 56 and fluid lumen58 are provided at an angle and extend in the longitudinal direction ofthe spike member 14. A radius R of the edges of the cut-outs C1, C2 maybe at least 0.05-0.1 mm or larger. In certain embodiments, the length ofthe fluid lumen 58 and the vent lumen 56 are optimized to fit thethickest stopper or septum 84 used for the second container 26 in orderto be utilized with the majority of commercially available stoppers.

Referring to FIG. 17, the placement of the distal openings 66, 68 of thevent lumen 56 and fluid lumen 58 in relation to the hook elements 34along the longitudinal axis of the spike member 14 determines the distalopenings 66, 68 placement in relation to the bottom of the stopper 84.The distance L, which may be approximately 0.64 mm in an exemplaryembodiment, separates the planar surface of the hook protrusion 42 ofthe hook element 34 and the proximal opening 64 of the fluid lumen 58along the longitudinal axis of the spike member 14. Distance h, whichmay be approximately 1.67 mm in an exemplary embodiment, separates thedistal opening 68 of the fluid lumen 58 and the proximal opening 62 ofthe vent lumen 56 along the longitudinal axis of the spike member 14.

Referring to FIGS. 17 and 19, the relatively large volume of the spikemember 14 is advantageous because the spike member 14 fills a deadvolume V between the stopper 84 and the spike member 14 that would becreated by a thinner spike, which is illustrated in FIG. 19.

Referring to FIG. 11, the relationship between an angle A of the distalend 54 of the spike member 14 and the length L1 of the distal openings66, 68 of the vent lumen 56 and the fluid lumen 58 along thelongitudinal axis can be defined by: L1=D6/tan(A/2)=D5/tan(a/2), whereD6 is the diameter of the vent lumen 56, D5 is the diameter of the fluidlumen 58, and angle a is a cut-out angle of the fluid lumen 58. In oneembodiment, the angle A and cut-out angle are smaller sized or optimizedfor easier penetration of the stopper 84 of the second container 26. Inone embodiment, the length L1 of the distal openings 66, 68 of the spikemember 14 are shorter in the longitudinal direction of the spike member14 than the thickness of the thinnest stopper according to ISO8362-2:2008 in order to prevent leakage during penetration of thestopper 84. If the distal openings 66, 68 are longer than the thicknessof the stopper 84, there will be an open channel for a short time duringpenetration and leakage may occur through the open channel due to thepressurized contents of the second container 26.

Referring to FIG. 17, in an exemplary embodiment, the distal opening 66of the vent lumen 56 is positioned as close to the distal end 54 of thespike member 14 (i.e., near the pointed tip 60) as possible and as faraway from the distal opening 68 of the fluid lumen 58 as possible tominimize the risk of air entering the fluid lumen 58 when extractingliquid from the second container 26.

Referring to FIG. 21, a further embodiment of a vial access device 100is shown. The vial access device 100 shown in FIG. 21 is the same as thevial access device 10 described above and shown in FIGS. 1-20 exceptthat the vial access device 100 of the present embodiment includes alubricant coating 102 applied to an exterior surface of the spike member14. The lubricant coating 102 reduces the friction caused by thepenetration of the spike member 14 into the stopper 84 of the secondcontainer 26. The lubricant coating 102 may be silicone-based, althoughother suitable lubricant coatings may be utilized. In an exemplaryembodiment, the lubricant coating 102, which is shown by cross-hatchingin FIG. 21, is applied close to the pointed tip 60 of the spike member14 and over the distal openings 66, 68 of the fluid lumen 58 and thevent lumen 56. The lubricant coating 102 can be applied by a modifiedtransfer pad (tampon) printing process and migrates over time to coverapproximately 70% of the surface of the spike member 14, although othersuitable processes for applying the coating 102 may be utilized.

The individual components used in the exemplary vial access devices 10,100 disclosed herein can be based on existing designs and componentswhich are known in the art. The following additional U.S. patentdocuments, which are incorporated by reference herein, discloseexemplary components and subsystems which may be used in the practice ofthe present invention: U.S. Pat. Nos. 6,343,629; 6,409,708; 6,715,520;8,075,550; 2010/0147402; 2011/0125128; and D637,713.

While certain exemplary embodiments of the present invention have beenshown and described herein with reference to certain preferredembodiments thereof, it will be understood by those skilled in the artthat various changes in form and details may be made therein withoutdeparting from the spirit and scope of the invention.

What is claimed is:
 1. A vial access device comprising: a housing havingfirst and second connectors, the first connector configured to besecured to a first container, the second connector configured to besecured to a second container; a spike member extending from the housingand having a proximal end and a distal end, the spike member having apointed end portion provided at the distal end thereof, the pointed endportion having a smaller diameter than a remaining portion of the spikemember, the spike member defining a vent lumen and a fluid lumen spacedfrom the vent lumen, each of the vent lumen and the fluid lumen having adistal opening, wherein the distal openings of the vent lumen and thefluid lumen are each defined by a top edge and a bottom edge spacedaxially from the top edge, the bottom edge of the fluid lumen ispositioned above the distal opening of the vent lumen in a directionextending along a longitudinal axis of the spike member, and the distalopenings of the vent lumen and the fluid lumen are defined in thepointed end portion of the spike member, wherein an angle of the pointedend portion of the spike member measured relative to a longitudinal axisof the spike member is less than an angle of the distal opening of thefluid lumen measured relative to the longitudinal axis of the spikemember.
 2. The vial access device of claim 1, wherein outer portions ofthe top edges of the vent lumen and the fluid lumen are smooth andconfigured to substantially prevent coring of a stopper when penetratingthe stopper with the spike member.
 3. The vial access device of claim 2,wherein the top edges of the vent lumen and the fluid lumen arechamfered.
 4. The vial access device of claim 1, wherein a shape definedby a circumference of the spike member is only symmetric about one axisat a position between the proximal end of the spike member and thedistal opening of the fluid lumen, wherein the circumference of thespike member varies in size and shape between the proximal end of thespike member and the distal opening of the fluid lumen.
 5. The vialaccess device of claim 1, wherein the circumference of the spike memberis substantially oval-shaped.
 6. The vial access device of claim 1,wherein the spike member comprises a ring extending radially outwardfrom the spike member, wherein the ring is configured to engage aportion of a stopper upon penetrating the stopper with the spike member,and wherein a circumference of a portion of the spike member that ispositioned distally of the ring is larger than a circumference of aportion of the spike member that is positioned adjacent to the distalopenings of the vent and fluid lumens.
 7. The vial access device ofclaim 1, wherein the bottom edge of the fluid lumen is positioned atabout the top edge of the vent lumen.
 8. The vial access device of claim1, wherein the distal end of the spike member is pointed and configuredto pierce a stopper.
 9. The vial access device of claim 8, wherein thedistal opening of the fluid lumen extends in a longitudinal direction ofthe spike member.
 10. The vial access device of claim 1, furthercomprising a lubricant coating positioned on the spike member.
 11. Thevial access device of claim 10, wherein the lubricant coating ispositioned adjacent to the distal end of the spike member.
 12. The vialaccess device of claim 1, further comprising a pressure equalizationchamber in fluid communication with the vent lumen.
 13. The vial accessdevice of claim 1, further comprising a pierceable membrane positionedadjacent to the first connector, the pierceable membrane covering aproximal opening of the fluid lumen.
 14. The vial access device of claim1, wherein the first connector comprises a neck portion of the housingdefining an opening that is configured to receive a correspondingconnector of a syringe adapter.
 15. The vial access device of claim 1,wherein a cross-section transverse to a longitudinal axis of the spikemember includes a y-axis and an x-axis, wherein a dimension of the spikemember along the x-axis adjacent to the fluid lumen is larger than adimension of the spike member along the x-axis adjacent to the ventlumen.
 16. A vial access device comprising: a housing having first andsecond connectors, the first connector configured to be secured to afirst container, the second connector configured to be secured to asecond container; a spike member extending from the housing and having aproximal end and a distal end, the spike member having a pointed endportion provided at the distal end thereof, the pointed end portionhaving a smaller diameter than a remaining portion of the spike member,the spike member defining a vent lumen and a fluid lumen spaced from thevent lumen, each of the vent lumen and the fluid lumen having a distalopening, wherein the distal openings of the vent lumen and the fluidlumen are each defined by a top edge and a bottom edge spaced axiallyfrom the top edge, the bottom edge of the fluid lumen is positionedabove the distal opening of the vent lumen in a direction extendingalong a longitudinal axis of the spike member, and the distal openingsof the vent lumen and the fluid lumen are defined in the pointed endportion of the spike member, wherein a cross-section transverse to alongitudinal axis of the spike member includes a y-axis and an x-axis,wherein a dimension of the spike member along the x-axis adjacent to thefluid lumen is larger than a dimension of the spike member along thex-axis adjacent to the vent lumen.